Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
This clinical trial is a multicenter, open-label, dose range-finding and multiple cohort dose expansion Phase Ib Clinical Trial-Lung Cancer Population.The goal of this study is to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
328
HC010 once every 3 weeks (Q3W) by intravenous drip
the combination chemotherapy regimens are all commonly used in clinical practice
the combination chemotherapy regimens are all commonly used in clinical practice
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence of dose-limiting toxicities (DLTs)
Time frame: From first dose to 21 days
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria;
Time frame: Up to approximately 2 years
Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 2 years
Maximum concentration (Cmax) of HC010
Time frame: Up to approximately 2 years
Number of positive cases of HC010 anti-drug antibody (ADA)
Time frame: Up to approximately 2 years
Area under the curve (AUC) of HC010
Time frame: Up to approximately 2 years
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
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the combination chemotherapy regimens are all commonly used in clinical practice
the combination chemotherapy regimens are all commonly used in clinical practice
the combination chemotherapy regimens are all commonly used in clinical practice